Will SGLT2 Inhibitors Face A Recall?

SGLT2 inhibitors are a special type of medication used to control Type II Diabetes. People with Type II Diabetes struggle to control their blood sugar levels (also referred to as their glucose levels). SGLT2 drugs (such as Invokana) help diabetics control their blood sugar numbers by stopping the body from absorbing all of the sugar. Instead, some of the extra sugar comes out of the body during the urination process. This type of drug is also different from other kinds designed to control glucose readings because it doesn’t involve the pancreas.

SGLT2 Inhibitors Cause Serious Side-Effects

While all medications generally come with a risk of side-effects, they’re usually mild. Yet, SGLT2 inhibitors have been linked to serious side-effects:

Diabetic ketoacidosis. Diabetic ketoacidosis is a medical emergency and requires immediate medical care. It can lead to death.

Permanent kidney damage. SGLT2 inhibitors have been linked to permanent kidney damage. This is devastating news for people with Type II Diabetes because they’re already at a higher risk for these issues. Additionally, use of SGLT2s have been linked to this damage occurring without any sort of warning.

An increase in the chance of amputation of toes or feet. Type II Diabetes creates an increased risk of neuropathy which can lead to wounds that don’t heal and can ultimately lead to necrosis and the need for amputation. While SGLT2 inhibitors are designed to help control blood sugar, they’ve recently been linked to an increase in amputation of toes, feet, and legs according to the FDA.

Serious urinary tract infections. The sugar that is blocked from absorption is passed through the urinary tract so it can enter the body. This sugar can cause you to develop serious urinary tract infections that can cause permanent kidney damage.

Increased risk of stroke. In 2015, the FDA warned of an increased risk of strokes for patients who use an SGLT2 inhibitor.

Will SGLT2 Inhibitors Face a Recall in the Future?

Whether an SGLT2 recall by the FDA is on the horizon remains to be seen. However, the FDA is aware of the serious side-effects that plague patients across the United States and in Canada. More than 800 lawsuits have been filed with claims of life-changing injuries from the use of an SGLT2 inhibitor.

Despite the short amount of time these drugs have been approved by the FDA, a handful of safety communications have been released by the FDA to warn of the potential risks. In May 2015, the FDA warned of the increased risk of patients developing ketoacidosis. In December 2015, the FDA warned of the increased risk of serious urinary tract infections. In May and June of 2016, the FDA warned of an increase in the risk of amputations and then strengthened their warning about the risk of acute kidney injuries. At that time, the FDA also made the manufacturers change their labels to warn about the risk of kidney problems. In May 2017, the FDA issued a black box warning, which is their most serious warning, that described the increase in risk for amputations.

With the increasingly serious nature of the safety communications, labels, and warnings, a recall by the FDA may happen, but there’s no way to know with certainty. If you’re taking an SGLT2 inhibitor, talk to your doctor before stopping your medication and ask about your options. Make sure that you know how to spot the signs of ketoacidosis, urinary tract infections, kidney problems, strokes, and neuropathy. Get medical care right away if you notice any of the symptoms of those serious side-effects.